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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes:
The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.
The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care.
The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCC intervention | Experimental | The BCC program consists of three group sessions and is delivered by two trained dietitians. In addition to the BCC program, the participants receive regular medical care in the diabetes clinic |
|
| ABC-ACC intervention | Experimental | The ABC-ACC program consists of one group session and two individual follow-up sessions and is delivered by trained dietitians with supervision by a medical doctor. In addition to the ABC-ACC program, the participants receive regular medical care in the diabetes clinic |
|
| Standard dietary education | Active Comparator | The routine outpatient dietary care consists of three individual consultations delivered by a trained dietitian. The individual guidance is based on the overall treatment goal(s), the defined personal dietary goals for behavioral change which will be in accordance with the patient's needs and preferences. In addition to the dietary counselling, the participants receive regular medical care in the diabetes clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCC intervention | Behavioral | Structured training and education i basic carbohydrate counting principles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | mmol/mol | Baseline, 6 months |
| Change in mean amplitude of glycaemic excursions (MAGE) | mmol/l | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | mmol/mol | 12 months |
| Change in body weight | kg | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity level | Total score or percent (%) | Baseline, 6 months, 12 months |
| Change in urinary biomarkers of carbohydrate intake | Percent (%) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Ewers, MSc | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Gentofte Municipality | DK-2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31481560 | Derived | Ewers B, Vilsboll T, Andersen HU, Bruun JM. The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes. BMJ Open. 2019 Sep 3;9(9):e029859. doi: 10.1136/bmjopen-2019-029859. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2019 | Dec 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2024 | Jan 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ABC-ACC intervention | Behavioral | Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate |
|
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| Standard dietary education | Behavioral | Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences |
|
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| Change in low-density lipoprotein cholesterol (LDL-C) | mmol/l | Baseline, 6 months, 12 months |
| Change in high-density cholesterol (HDL-C) | mmol/l | Baseline, 6 months, 12 months |
| Change in total cholesterol (TC) | mmol/l | Baseline, 6 months, 12 months |
| Change in free fatty acids (FFA) | mmol/l | Baseline, 6 months, 12 months |
| Change in triglycerides (TG) | mmol/l | Baseline, 6 months, 12 months |
| Change in systolic blood pressure | mm Hg | Baseline, 6 months, 12 months |
| Change in diastolic blood pressure | mm Hg | Baseline, 6 months, 12 months |
| Change in waist circumference | cm | Baseline, 6 months, 12 months |
| Change in hip circumference | cm | Baseline, 6 months, 12 months |
| Change in total fat free mass | gram | Baseline, 6 months |
| Change in total fat mass | gram | Baseline, 6 months |
| Change in time in range (3.9-10.0 mmol/l) | Percent (%) | Baseline, 6 months |
| Changes in % time spent in hypoglycaemia (<3.9 mmol/l) | Percent (%) | Baseline, 6 months |
| Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l) | Percent (%) | Baseline, 6 months |
| Change in standard deviation of mean plasma glucose | mmol/l | Baseline, 6 months |
| Change in mathematical literacy | Total score or percent (%) | Baseline, 6 months, 12 months |
| Change in carbohydrate estimation accuracy | Total score or percent (%) | Baseline, 6 months, 12 months |
| Change in diet-related quality of life | Total score or percent (%) | Baseline, 6 months, 12 months |
| Change in perceived competences in diabetes | Total score or percent (%) | Baseline, 6 months, 12 months |
| Change in degree of autonomy-supportive dietitian | Total score or percent (%) | Baseline, 6 months, 12 months |
| Change in total energy intake | kJ/day | Baseline, 6 months |
| Change in dietary intake of carbohydrates | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of total fat | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of saturated fatty acids (SFA) | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of monounsaturated fatty acids (MUFA) | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of polyunsaturated fatty acids (PUFA) | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of protein | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in dietary intake of added sugar | gram/day or percent of total energy (E%) | Baseline, 6 months |
| Change in intake of dietary fibre | gram/day or g/MJ | Baseline, 6 months |
| Baseline, 6 months |